The U.S. FDA’s release of its briefing document for the upcoming advisory committee meeting on obeticholic acid 25 mg as a fatty liver disease treatment sent Intercept Pharmaceuticals Inc. on a downwards spiral May 17. Soon after the document was released, Intercept stock (NASDAQ:ICPT) dropped as low as $11.41 – down almost 30% from its May 16 close of $16.21. As the day wore on, it regained some of that lost value in heated trading that was more than eight times the company’s average daily volume of 782,285. The rebound helped Intercept close the day at $13.83, down about 15%.
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.
Therabest Co. Ltd. has identified glutathione (GSH) or hydrogen peroxide (H2O2)-activated prodrugs comprising obeticholic acid dimers conjugated via linkers and their nanogels coated with fucoidan reported to be useful for the treatment of liver diseases.
Echosens SA obtained clearance from the U.S. FDA to expand the indications for screening with its Fibroscan system. The approval removes contraindications for pregnancy and active implant and includes patients with confirmed or suspected liver disease. It designates Fibroscan as a noninvasive aid for clinical management, diagnosis and monitoring of adult and pediatric patients with liver diseases. The age has been removed as the first selection probe and exam-type step.
89bio Inc.’s top-line phase IIb data from the 216-subject study called Enliven testing pegozafermin in nonalcoholic steatohepatitis (NASH) pushed shares (NASDAQ:ETNB) to a closing price March 22 of $13.68, up $2.75, or 25%. The drug, due next for phase III investigation, is a glycopegylated analogue of fibroblast growth factor 21.
Researchers from the University of Illinois Urbana-Champaign have published data from a study designed to assess the role of serine-arginine-rich splicing factor 1 (SRSF1) in hepatocyte function and survival.
Perspectum Diagnostics Ltd. reported the first close at $36 million of its series C round, with the majority of the new money due to be invested in expanding U.S. uptake of its Livermultiscan diagnostic for assessing and monitoring chronic liver disease.
Hightide Therapeutics Inc. closed a $107 million series C round that will advance multiple global development programs for lead candidate HTD-1801, including a phase III trial in type 2 diabetes.
